Systems and methods for aerosol delivery of agents

• US 7,225,807 B2
• Filed: 03/13/2002
• Issued: 06/05/2007
• Est. Priority Date: 03/15/2001
• Status: Expired due to Term

• Current Assignee: Creare Incorporated, United States Department Of Health And Human Services (Government of the United States of America)
• Original Assignee: Creare Incorporated, The United States of America As Represented By The Secretary of Agriculture
• Inventors: Barry, James J., Elkouh, Nabil A., Bagley, Mark C., Papania, Mark James
• Primary Examiner(s): Yu; Justine R.
• Assistant Examiner(s): MATTER, KRISTEN CLARETTE
• Application Number:
  US10/471,620
• Publication Number:
  US 20040134494A1
• Time in Patent Office: 1,910 Days
• Field of Search: 128/203.12, 128/203.14, 128/203.25, 128/200.22, 128/205.24, 128/200.14, 128/200.16, 128/200.18, 128/200.21
• US Class Current: 128/203.12
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 15/0033 Details of the piercing or cutting means
• CPC Class Codes: A61M 15/0066 with means for varying the dose size
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 16/14 by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: A61M 2205/07 having air pumping means
• CPC Class Codes: A61M 2205/071 hand operated
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8225 using incorporated gas cartridges for the driving gas
• CPC Class Codes: A61M 2205/825 using mechanical generation of electricity, e.g. hand cranked generators
• CPC Class Codes: B05B 17/0676 Feeding means

Abstract

Aerosol delivery systems and methods for delivering an agent to a patient are described herein. The present invention includes embodiments comprising an insulated receptacle connected to a body to hold a vial of an agent to be delivered to a patient. The vial is located in an inverted position within the receptacle and connected to the housing. One or more reusable thermal packs can be located on the inner sides of the receptacle, to maintain a selected temperature surrounding the vial. The agent is administered to a patient by placing a prong into one of the patient'"'"'s orifices and then activating an aerosol delivery system. Such systems comprise jet aerosolization and pneumatic and ultrasonic nebulizers and preferably are portable.

Claims

1. A system for administering an agent, comprising:

a housing;

an air source operable to provide positive pressure air;

a nebulizer operable for receiving an agent from a vial coupled to the housing and converting the agent into an aerosolized agent;

a mixing chamber to receive the aerosolized agent from the nebulizer and air from the air source;

a release mechanism operable for releasing a quantity of the agent from the vial to the nebulizer, wherein the agent is converted into an aerosolized agent that is mixed with air from the air source in the mixing chamber;

a prong with an inlet and an outlet, wherein the inlet is operable to receive the aerosolized agent and air mixture from the mixing chamber, and the outlet is operable to deliver the aerosolized agent and air mixture to a patient when the prong is inserted into a patient'"'"'s orifice;

an anti-backflow valve between the mixing chamber and the prong outlet, operable to permit flow from the mixing chamber to the prong, and to inhibit flow in a reverse direction; and

a cooling chamber connected to the housing, the cooling chamber being adapted to receive the vial and being operable to maintain the agent at a selected temperature.

2. The system of claim 1, wherein the air source is contained within the housing.

3. The system of claim 1, which further comprises a source of electrical energy connected to the nebulizer.

4. The system of claim 1, wherein the air source comprises a compressed air chamber coupled to said housing.

5. The system of claim 1, wherein said air source comprises an external source of compressed air.

6. The system of claim 1, wherein the release mechanism comprises a manually activated trigger on said housing.

7. The system of claim 6, wherein said trigger is operatively coupled to said nebulizer and air source such that upon actuation of the trigger the nebulizer produces aerosolized agent and air under pressure is mixed with the aerosolized agent for delivery to a patient.

8. The system of claim 6 which further comprises a timing circuit, which upon activation of the trigger controls the timing of the release of agent from the vial to the nebulizer, conversion of the agent into an aerosol, mixture of the aerosolized agent with air, and delivery of the aerosolized agent and air mixture to a patient.

9. The system of claim 1, wherein the prong comprises a hollow tube configured to fit closely in a patient'"'"'s naris.

10. The system of claim 1, wherein the prong comprises multiple internal channel portions in angularly disposed relation to each other so that a direct path does not exist from the prong outlet through the anti-backflow valve.

11. The system of claim 1, which further comprises an agent probe operable to extend into said vial to permit drawing the agent from the vial.

12. The system of claim 11, which further includes a vent probe capable of extending into the vial to admit air into the vial as agent is drawn therefrom via said agent probe.

13. The system of claim 1, wherein said air source comprises an air chamber within said housing.

14. The system of claim 1, wherein said air source comprises a manually actuated pump on said housing.

15. The system of claim 1, which further comprises a battery coupled to said housing and connected to the nebulizer.

16. The system of claim 15, wherein said battery is rechargeable, and said system comprises an AC power converter coupled to said housing.

17. The system of claim 15, wherein said battery is rechargeable, and which further comprises a manually actuated dynamo mounted on said housing and operatively connected to said battery for recharging the battery.

18. The system of claim 1, wherein the prong comprises an elongate tubular member having an aerosol inlet portion adjacent one of its ends and a patient engaging portion adjacent its opposite end configured to fit closely in a patient'"'"'s orifice.

19. The system of claim 18, wherein said anti-backflow valve is positioned in said prong intermediate said aerosol inlet portion and patient engaging portion.

20. The system of claim 1, wherein said prong comprises a prong body and said anti-backflow valve comprises a valve seat, a valve closure member shiftable toward and away from the valve seat between closed and opened positions, and a plurality of support members operatively connecting said valve member to the prong body permitting shifting of the valve member between its opened and closed positions under the influence of the direction of air pressure imposed upon the valve member.

21. The system of claim 20, wherein said valve member is substantially conical.

22. The system of claim 20, wherein said support members comprise leaf springs.

23. The system of claim 1, wherein said nebulizer comprises an ultrasonic nebulizer.

24. The system of claim 23, wherein said ultrasonic nebulizer comprises a piezoelectric actuator operatively connected to a power source.

25. The system of claim 1, wherein said nebulizer comprises an element having a plurality of openings extending therethrough through which agent is distributed upon actuation of the nebulizer to produce droplets of agent in a size range of from 4 to 10 microns.

26. The system of claim 1, wherein the cooling chamber comprises a replaceable ice pack.

27. The system of claim 1, wherein the vial has a selected external configuration, and said cooling chamber has an internal configuration shaped to closely fit about the external configuration of said vial.

28. A system for administering an agent, comprising:

a housing

an air source operable to provide positive pressure air;

a nebulizer operable for receiving an agent from a vial coupled to the housing and converting the agent into an aerosolized agent;

a mixing chamber to receive the aerosolized agent from the nebulizer and air from the air source;

a release mechanism operable for releasing a quantity of the agent from the vial to the nebulizer, wherein the agent is converted into an aerosolized agent that is mixed with air from the air source in the mixing chamber;

a prong with an inlet and an outlet, wherein the inlet is operable to receive the aerosolized agent and air mixture from the mixing chamber, and the outlet is operable to deliver the aerosolized agent and air mixture to a patient when the prong is inserted into a patient'"'"'s orifice; and

an anti-backflow valve between the mixing chamber and the prong outlet, operable to permit flow from the mixing chamber to the prong, and to inhibit flow in a reverse direction;

wherein said nebulizer comprises an element having a plurality of openings extending therethrough through which agent is distributed upon actuation of the nebulizer to produce droplets of agent in a size range of from 4 to 10 microns;

wherein said nebulizer comprises a pair of spaced apart plate members defining a liquid-receiving chamber therebetween adapted to receive a quantity of agent from the vial, one of said members having a plurality of orifices extending therethrough through which liquid may be forced from the chamber to produce droplets of agent, and the system further comprises actuating mechanism operable to reciprocate at least one of said members toward the other in a compression actuation to force liquid from said chamber through said orifices.

29. The system of claim 28, wherein said chamber is operatively coupled to said vial whereby agent may flow from said vial to the chamber, and upon movement of the elements away from their compression actuation serves to draw agent from the vial into the chamber.

30. The system of claim 28, wherein said actuating mechanism comprises an operator coupled to one of said plate members, operable to reciprocate said one plate member toward and away from the other of said plate members.

31. The system of claim 30, wherein said operator comprises a reciprocating member mounted for reciprocation toward and away from one of said plate members, such that upon extension the reciprocating member presses said one member toward the other member, and upon retraction allows said one member to move away from the other member.

32. The system of claim 31, wherein said reciprocating member comprises a fluid-actuated reciprocating piston operatively connected to said air source whereby application of positive pressure air thereto produces reciprocation of the piston to produce aerosolized agent and also to channel air into the mixing chamber to mix with the aerosolized agent.

33. The system of claim 32, which further comprises a biasing element operatively coupled to said piston to assist in reciprocation thereof.